US FDA approves Eisai's Halaven for metastatic breast cancer and expanded use for Shire's Vyvanse

In a couple of positive opinions announced yesterday, the US Food and Drug Administration approved Japanese drug major Eisai’s (TYO: 4523) breast cancer drug Halaven (eribulin mesylate) and Ireland-headquartered Shire’s (LSE: SHP) attention-deficit hyperactivity disorder (ADHA) treatment Vyvanse (lisdexamfetamine dimesylate) for a wider population.

Halaven Injection was cleared for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer. Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.

The FDA clearance came earlier than expected and, according to a Bloomberg report quoting Eisai’s chief executive Haruo Naito at a press conference in Tokyo, the company aims to launch the drug in the USA on November 26, a day after its leading Alzheimer’s drug Aricept () loses its US patent, and is aiming for annual sales of more than $1 billion. Eisai’s shares rose as much as 1.7% to 2,916 yen on the news.